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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by FDC Limited

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    FDC Limited
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    Country
    Country
    India
    Address
    Address
    FDC LIMITEDB-8, MIDC AreaWaluj - 431 136Dist. AurangabadMaharashtra
    Telephone
    Telephone
    0240 - 2554407 / 2554299 / 2554967
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.fdcindia.com/
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    Flurbiprofen

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    USDMF

    Found USDMF

    8219
    Active
    FLURBIPROFEN USP
    1989-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-382 - Rev 00
    Valid
    Flurbiprofen, Process 2
    2023-01-26
    Japanese DMF

    Found JDMF

    219MF10187
    FLURBIPROFEN at 142-48,s,v,road,jog...
    2007-06-01
    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Flurbiprofen (BP/USP/EP/IP/JP)
    2022-06-08
    Application Number
    8219
    R0-CEP 2022-382 - Rev 00
    219MF10187
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    FLURBIPROFEN USP
    Flurbiprofen, Process 2
    FLURBIPROFEN at 142-48,s,v,road,jog...
    Flurbiprofen (BP/USP/EP/IP/JP)
    Issue/Submission Date
    1989-09-07
    2023-01-26
    2007-06-01
    2022-06-08
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    Timolol Maleate

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    USDMF

    Found USDMF

    9839
    Active
    TIMOLOL MALEATE USP
    1992-07-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-070 - Rev 03
    Valid
    Timolol maleate
    2020-09-15
    Japanese DMF

    Found JDMF

    227MF10140
    Timolol maleate at 142-48,s,v,road,...
    2015-05-14
    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Timolol Maleate (BP/EP/USP/IP/JP)
    2022-06-08
    Application Number
    9839
    R1-CEP 2003-070 - Rev 03
    227MF10140
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-07
    Filing Details
    TIMOLOL MALEATE USP
    Timolol maleate
    Timolol maleate at 142-48,s,v,road,...
    Timolol Maleate (BP/EP/USP/IP/JP)
    Issue/Submission Date
    1992-07-27
    2020-09-15
    2015-05-14
    2022-06-08
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    Brimonidine Tartrate

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    USDMF

    Found USDMF

    20855
    Active
    BRIMONIDINE TARTRATE USP
    2007-09-17
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-123 - Rev 00
    Valid
    Brimonidine tartrate
    2022-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Brimonidine Tartrate (IH/IP/EP)
    2022-06-08
    Application Number
    20855
    R0-CEP 2020-123 - Rev 00
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    BRIMONIDINE TARTRATE USP
    Brimonidine tartrate
    Brimonidine Tartrate (IH/IP/EP)
    Issue/Submission Date
    2007-09-17
    2022-06-13
    2022-06-08
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    Bromhexine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-032 - Rev 03
    Valid
    Bromhexine hydrochloride
    2023-01-23
    Japanese DMF

    Found JDMF

    305MF10115
    Bromhexine Hydrochloride at 142-48,...
    2023-10-12
    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Bromhexine Hydrochloride (BP/EP/IP/...
    2022-06-08
    Application Number
    R1-CEP 2007-032 - Rev 03
    305MF10115
    Indian CDSCO WC-0055
    Status
    Valid
     
    Valid
    2025-07-07
    Filing Details
    Bromhexine hydrochloride
    Bromhexine Hydrochloride at 142-48,...
    Bromhexine Hydrochloride (BP/EP/IP/...
    Issue/Submission Date
    2023-01-23
    2023-10-12
    2022-06-08
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    Cinnarizine

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    USDMF

    Found USDMF

    31934
    Active
    CINNARIZINE
    2017-09-07
    CEP/COS

    Found CEP/COS

    CEP 2003-150 - Rev 03
    Valid
    Cinnarizine
    2023-09-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Cinnarizine (BP/EP/IP)
    2022-06-08
    Application Number
    31934
    CEP 2003-150 - Rev 03
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    CINNARIZINE
    Cinnarizine
    Cinnarizine (BP/EP/IP)
    Issue/Submission Date
    2017-09-07
    2023-09-08
    2022-06-08
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    Econazole Nitrate

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    USDMF

    Found USDMF

    10456
    Active
    ECONAZOLE NITRATE USP
    1993-08-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-133 - Rev 01
    Valid
    Econazole nitrate
    2021-03-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Econazole Nitrate (BP/EP)
    2022-06-08
    Application Number
    10456
    R1-CEP 2003-133 - Rev 01
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    ECONAZOLE NITRATE USP
    Econazole nitrate
    Econazole Nitrate (BP/EP)
    Issue/Submission Date
    1993-08-09
    2021-03-12
    2022-06-08
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    Miconazole Nitrate

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    USDMF

    Found USDMF

    7376
    Active
    MICONAZOLE NITRATE USP
    1988-03-04
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-146 - Rev 03
    Valid
    Miconazole nitrate
    2020-08-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Miconazole Nitrate (BP/EP/USP)
    2022-06-08
    Application Number
    7376
    R1-CEP 1998-146 - Rev 03
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-07
    Filing Details
    MICONAZOLE NITRATE USP
    Miconazole nitrate
    Miconazole Nitrate (BP/EP/USP)
    Issue/Submission Date
    1988-03-04
    2020-08-18
    2022-06-08
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    Salbutamol Sulphate

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    USDMF

    Found USDMF

    7809
    Active
    ALBUTEROL SULFATE USP
    1988-12-12
    CEP/COS

    Found CEP/COS

    CEP 2015-212 - Rev 01
    Valid
    Salbutamol sulfate
    2024-02-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Salbutamol Sulfate (BP/EP)/Albutero...
    2022-06-08
    Application Number
    7809
    CEP 2015-212 - Rev 01
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-07
    Filing Details
    ALBUTEROL SULFATE USP
    Salbutamol sulfate
    Salbutamol Sulfate (BP/EP)/Albutero...
    Issue/Submission Date
    1988-12-12
    2024-02-01
    2022-06-08
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    Dorzolamide Hydrochloride

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    USDMF

    Caution USDMF

    20856
    Inactive
    DORZOLAMIDE HYDROCHLORIDE USP
    2007-09-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-288 - Rev 00
    Valid
    Dorzolamide hydrochloride
    2021-03-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Dorzolamide Hydrochloride (EP/BP)
    2022-06-08
    Application Number
    20856
    R1-CEP 2014-288 - Rev 00
    Indian CDSCO WC-0055
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    DORZOLAMIDE HYDROCHLORIDE USP
    Dorzolamide hydrochloride
    Dorzolamide Hydrochloride (EP/BP)
    Issue/Submission Date
    2007-09-17
    2021-03-02
    2022-06-08
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    Fluconazole

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    USDMF

    Caution USDMF

    16632
    Inactive
    FLUCONAZOLE
    2003-06-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-286 - Rev 00
    Valid
    Fluconazole
    2023-07-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Fluconazole (EP/USP)
    2022-06-08
    Application Number
    16632
    R1-CEP 2016-286 - Rev 00
    Indian CDSCO WC-0055
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    FLUCONAZOLE
    Fluconazole
    Fluconazole (EP/USP)
    Issue/Submission Date
    2003-06-12
    2023-07-04
    2022-06-08
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    Miconazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24879
    Inactive
    MICONAZOLE USP
    2011-04-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-233 - Rev 00
    Valid
    Miconazole
    2023-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Miconazole (BP/EP/USP)
    2022-06-08
    Application Number
    24879
    R0-CEP 2022-233 - Rev 00
    Indian CDSCO WC-0055
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-07
    Filing Details
    MICONAZOLE USP
    Miconazole
    Miconazole (BP/EP/USP)
    Issue/Submission Date
    2011-04-21
    2023-08-04
    2022-06-08
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    Dorzolamide Hydrochloride

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    USDMF

    Found USDMF

    33576
    Active
    DORZOLAMIDE HYDROCHLORIDE USP (PROC...
    2019-04-02
    CEP/COS

    Found CEP/COS

    CEP 2023-236 - Rev 00
    Valid
    Dorzolamide hydrochloride, Process ...
    2023-09-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33576
    CEP 2023-236 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DORZOLAMIDE HYDROCHLORIDE USP (PROC...
    Dorzolamide hydrochloride, Process ...
    Issue/Submission Date
    2019-04-02
    2023-09-07
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    • FDA
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    Flurbiprofen

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-103 - Rev 03
    Valid
    Flurbiprofen
    2022-10-18
    Japanese DMF

    Found JDMF

    218MF10559
    Japanese Pharmacopoeia flurbiprofen...
    2006-06-02
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2003-103 - Rev 03
    218MF10559
    Status
    Valid
     
    Filing Details
    Flurbiprofen
    Japanese Pharmacopoeia flurbiprofen...
    Issue/Submission Date
    2022-10-18
    2006-06-02
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    Latanoprost

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    USDMF

    Found USDMF

    23813
    Active
    LATANOPROST USP
    2010-05-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Latanoprost (IH)
    2022-06-08
    Application Number
    23813
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-07
    Filing Details
    LATANOPROST USP
    Latanoprost (IH)
    Issue/Submission Date
    2010-05-18
    2022-06-08
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    Olopatadine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29464
    Active
    OLOPATADINE HYDROCHLORIDE USP
    2015-06-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    OLOPATADINE HCl (USP)
    2022-06-08
    Application Number
    29464
    Indian CDSCO WC-0055
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-07
    Filing Details
    OLOPATADINE HYDROCHLORIDE USP
    OLOPATADINE HCl (USP)
    Issue/Submission Date
    2015-06-23
    2022-06-08
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    31823
    Inactive
    TELMISARTAN USP
    2017-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Telmisartan USP
    2022-06-08
    Application Number
    31823
    Indian CDSCO WC-0055
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-07
    Filing Details
    TELMISARTAN USP
    Telmisartan USP
    Issue/Submission Date
    2017-08-01
    2022-06-08
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    Betaxolol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2022-334 - Rev 00
    Valid
    Betaxolol hydrochloride
    2024-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2022-334 - Rev 00
    Status
    Valid
     
    Filing Details
    Betaxolol hydrochloride
    Issue/Submission Date
    2024-02-08
    ASK
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    Flunarizine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Flunarizine Dihydrochloride (BP)/Fl...
    2022-06-08
    Application Number
    Indian CDSCO WC-0055
    Status
     
    Valid
    2025-07-07
    Filing Details
    Flunarizine Dihydrochloride (BP)/Fl...
    Issue/Submission Date
    2022-06-08
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    Flurbiprofen Sodium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Flurbiprofen Sodium (BP/USP)
    2022-06-08
    Application Number
    Indian CDSCO WC-0055
    Status
     
    Valid
    2025-07-07
    Filing Details
    Flurbiprofen Sodium (BP/USP)
    Issue/Submission Date
    2022-06-08
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    Rupatadine Fumarate

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0055
    Valid
    Rupatadine Fumarate (IH)
    2022-06-08
    Application Number
    Indian CDSCO WC-0055
    Status
     
    Valid
    2025-07-07
    Filing Details
    Rupatadine Fumarate (IH)
    Issue/Submission Date
    2022-06-08
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    BRINZOLAMIDE USP

    PDF Supplier PDF
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    USDMF

    Found USDMF

    39512
    Active
    BRINZOLAMIDE USP
    2024-03-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39512
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BRINZOLAMIDE USP
    Issue/Submission Date
    2024-03-06
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    Dantrolene

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    USDMF

    Caution USDMF

    17446
    Inactive
    DANTROLENE SODIUM
    2004-05-27
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    17446
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DANTROLENE SODIUM
    Issue/Submission Date
    2004-05-27
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    Diazepam

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    USDMF

    Caution USDMF

    7025
    Inactive
    DIAZEPAM U.S.P. XXI
    1987-06-18
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    7025
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DIAZEPAM U.S.P. XXI
    Issue/Submission Date
    1987-06-18
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    Ketoconazole

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    USDMF

    Caution USDMF

    16802
    Inactive
    KETOCONAZOLE
    2003-08-27
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    16802
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    KETOCONAZOLE
    Issue/Submission Date
    2003-08-27
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    Levalbuterol Hydrochloride

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    USDMF

    Caution USDMF

    21394
    Inactive
    LEVALBUTEROL HYDROCHLORIDE
    2008-03-05
    CEP/COS

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    Japanese DMF

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    Application Number
    21394
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LEVALBUTEROL HYDROCHLORIDE
    Issue/Submission Date
    2008-03-05
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    Metaxalone

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    USDMF

    Caution USDMF

    16449
    Inactive
    METAXALONE
    2003-03-04
    CEP/COS

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    Japanese DMF

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    Application Number
    16449
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METAXALONE
    Issue/Submission Date
    2003-03-04
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    Metronidazole

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    USDMF

    Caution USDMF

    7024
    Inactive
    METRONIDAZOLE U.S.P. XXI
    1987-06-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    7024
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METRONIDAZOLE U.S.P. XXI
    Issue/Submission Date
    1987-06-18
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    FACILS & GEN. OPERATING PROCEDS. FOR MFGR OF BULK DRUG ...

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    USDMF

    Caution USDMF

    4951
    Inactive
    FACILS & GEN. OPERATING PROCEDS. FO...
    1983-05-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    4951
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILS & GEN. OPERATING PROCEDS. FO...
    Issue/Submission Date
    1983-05-25
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    7102
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1987-08-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7102
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1987-08-07
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